In December 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”)—the most significant expansion of the U.S. Food and Drug Administration’s authority to regulate cosmetics in nearly 85 years—was signed into law. Among other things, MoCRA gives the FDA authority to require facility registration and reporting of serious adverse events, impose certain record-keeping obligations, recall cosmetic products, and establish good manufacturing practices. With many of MoCRA’s provisions going into effect at the end of this year, cosmetics companies need to prepare to address these requirements and regulations, which may also have a considerable impact on the litigation landscape.

Crowell’s Product Risk Management team has written two publications to help cosmetics companies prepare for the big changes ahead.

Continue Reading Modernization of Cosmetics Regulation Act (“MoCRA”) White Paper

On July 26, 2016, FDA issued an updated warning on beauty products, warning consumers to avoid certain “skin creams, beauty and antiseptic soaps, and lotions,” particularly those boasting “anti-aging” or “skin lightening” benefits, as potentially containing mercury.  While the dangers of mercury exposure are well-known, mercury’s ubiquity in certain beauty products is not.  Products that claim to “remove age spots, freckles, blemishes, and wrinkles,” including products targeting teenagers enduring acne, may contain mercury.  Checking the label can help—look out for words like “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or of course, “mercury”, but it’s not fool-proof.  As FDA points out, many of these beauty products are often made abroad and can be sold illegally in the U.S., without any labels. FDA continually monitors products like these, but is unable to catch all of them, especially due to their dubious channels of trade.  For those that FDA does catch, FDA sets up an import alert to prevent future influxes of such products.  Check here for all Consumer Updates from FDA.  Thus, retailers should do their due diligence to know what the chemical content is of the products they sell beyond the labels.

In its warning, FDA again mentioned one of its growing complaints levied against cosmetics – that the product may actually be an unapproved new drug under the law.
Continue Reading Beauty with a Side of Mercury?

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While a study hardly seems necessary to confirm it, an article published in the Journal of Global Fashion Marketing reports that of 289 cosmetics ads surveyed, only 18% could be viewed as generally trustworthy. While some may view this finding to be mere common sense, others – particularly plaintiffs’ counsel looking for potential class action claims – may view cosmetics as the next frontier after food labeling. After all, for an attorney with a “natural claim” lawsuit or similar complaint already drafted, the possibility of repurposing a ready-made legal formula may be highly appealing. Might cosmetics claims become the target of a new wave of false advertising litigation, akin to the “food wars”?

Continue Reading Is Makeup About to Get Ugly? Plaintiffs’ Counsel May See the High Promises of Some Cosmetics Advertisements as a Source of Litigation

128021458Perusing the labels at your typical cosmetics counter or pharmacy aisle can feel akin to reading the menu of options for a smoothie bar.  “Antioxidants,” “Aloe,” “Vitamin C,” “Almond extract,” “natural fruit,” and “protein” all appear to be popular options.  When it comes to specifics, labels often vary from saying that an ingredient is contained